Specialist, Clinical Research Lead

University of Maryland•Baltimore, MD

4d•$80,500 - $93,000•Hybrid

About The Position

The Division of Cardiovascular Medicine (CVM) for the University of Maryland, Baltimore (UMB) has an exciting opportunity for a Lead Clinical Research Specialist. The Division of Cardiovascular Medicine (CVM) is dedicated to patient care, research, and education and wants to ensure our place as a leader in cardiovascular treatment and research. Together with the University of Maryland Comprehensive Heart Center, we are dedicated to improving the lives of individuals with heart disease using the latest innovations in cardiovascular care. The selected candidate will perform duties that support the mission and vision of the department.

Requirements

Bachelor's degree in scientific field of study related to the research of the clinic.
Five (5) years clinical research including three (3) years in the relevant research specialization.
Knowledge of position requirements.
Knowledge of all applicable requirements, regulations, and laws.
Skill in effective use of applicable technology/systems.
Ability to effectively communicate both verbal and written thoughts, ideas, and facts.
Ability to work cooperatively with others and independently.
Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.

Nice To Haves

Master's degree in related field may be substituted for two (2) years of related experience.

Responsibilities

Leads the highest technical research and guides research programs, projects, and activities in a clinical setting.
Responsible for ensuring design, development, documentation and implementation of research procedures and protocols using a variety of complex activities.
Networks with faculty and staff to achieve strategic goals and maximize efficiency.
Develops, recommends, modifies, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforces standards.
Prepares for the Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols.
Coordinates developing and recommending policies and procedures and/or design methods for clinical research activities.
Leads the management and analysis of clinical research data to include data analysis using statistical software, data collection, data entry, data verification, and ensure compliance and clinical relevance of data.
Assists in the development and implementation of site tracking tools to comply with data monitoring requirements per federal regulations and guidance.
Independently cleans, validates, and analyzes research data to prepare research findings for publications of journal articles and grant proposals.
Leads the development of project timelines, work plan, recruitment strategy, and progress through the duration of the research study or clinical trial.
Collaborates with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trial.
Performs advanced clinical research activities including advanced data analysis using statistical software such as SAS, SPSS, and R; data management (collection, entry, verification); data interpretation and ensures compliance and clinical relevance of data.
May develop data collection instruments such as survey questionnaires.
Maintains communication with participants and colleagues regarding protocol specific information and research orders.
Provides assessments and ensure protocol compliance while participants are in a study.
Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources.
Oversee the management of day-to-day clinical research operations and leads study initiation, execution, and completion.
Assist in the design and provide expert recommendations regarding research studies.
Oversees interaction with subject participants including eligibility screening, recruitment, enrollment, ensuring informed consent is properly secured and documented, counseling, and obtaining patient medical history.
Provides working coordination and feedback to others.
Performs day-to-day operational duties such as: monitoring the budget; budget negotiation and review, ensuring quality control and safety compliance; serving as liaison with IRB, submitting invoicing, develop policies, procedures, and/or methods for laboratory experimentation; and ordering supplies.
Searches relevant literature, develops conclusions, writes reports, prepares, and delivers presentations of relevant findings and conclusions, and recommends appropriate actions.
Reviews analysis and reports of less experience members of the research team.
Trains and provides mentoring to other research personnel in implementation of research protocols, IRB submissions, research procedures, and policies, etc.
Serves as subject matter expert and provides guidance for staff, faculty, and leadership.
Develops protocol manuals and data collection instruments; participating in field visits, responding to requests and questions from individuals, institutions, government agencies, and funding agencies; and participating in the design of research studies.
Performs other duties as assigned.

Benefits

Participates in a retirement program (pension or optional retirement plan/ORP)
Generous PAID leave package
Over 4 weeks of vacation accrued each year
15 paid holidays
3 personal leave
Unlimited accrual of sick time
Comprehensive health insurance
Professional learning and development programs
Tuition remission for employees and their dependents at any University System of Maryland school
Flexible work schedules
Teleworking options (if applicable per job)